To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation

Inclusion Criteria:

1. Male or female ≥ 18 years of age or designated age of majority according to theregulatory authorities, whichever is higher.

2. Eastern Cooperative Oncology Group (ECOG) performance status (PS), 0 or 1.

3. Have a life expectancy of at least 3 months.

4. Diagnosis:

5. must have histologically or cytologically confirmed NSCLC, advanced, recurrent,or metastatic,

6. For Cohort 1: MET exon 14 skipping suspected by local or central biomarkerassessment. [local testing is accepted for eligibility; all patients will haveconfirmation by central laboratory, but this result is not necessary foreligibility; local molecular pathology result will suffice]. This testing canbe from archival or fresh tissue sample and/or blood specimen; any sample, anytest positive subjects are eligible.

7. For Cohort 2:

• Non-squamous histology (confirmed by histology or cytology)
• EGFR mutation-positive including exon 19 deletions or exon 21 L858R asdetected by an FDA-approved or other validated test in a CLIA certifiedlaboratory (sites in the US) or an accredited local laboratory (sitesoutside of the US) in accordance with site standard of care. (Note: A copyof the test report documenting the EGFR mutation must be included in theparticipant records and it must be reviewed by the Medical monitor.)
• Radiological documentation of disease progression while on continuoustreatment with the 1st line 3rd generation EGFR-TKI
• Prior objective clinical benefit defined by either partial or completeradiological response, or durable SD (SD should last > 6 months) from the 1st line 3rd generation EGFR-TKI
• Interval between documentation of radiological progression of disease onthe 1st line 3rd generation EGFR TKI and first dose of study drug shouldbe ≤ 60 days
• MET amplification or overexpression from tumor sample collected followingprogression on 1st line 3rd generation EGFR-TKI • Amplification GCN ≥ 10indicated by FISH (confirmed centrally, slides or image from locallaboratory will be confirmed by the central pathologist) or NGS (confirmedeither centrally or locally) • Overexpression indicated by IHC90+ (i.e. 3+staining in ≥ 90% tumor cells by central test, if local IHC results areavailable, image from local laboratory will be confirmed by centralpathologist. Despite the image submission, tissue unstained slides shouldbe sent to central laboratory for confirmation of MET amplification oroverexpression.)

5. Treatment experience

6. Cohort 1: Anti-tumor treatment naïve subject upon refusal to receive 1st linestandard of care, or not tolerated to 1st line standard of care, or progressedafter standard of care with no greater than 2 prior treatment regimens (neoadjuvant, adjuvant, and maintenance therapies do not qualify as separatetreatment regimens).

7. Cohort 2: Progressed on prior the 1st line 3rd generation EGFR-TKI for thetreatment of advanced/metastatic NSCLC

8. At least one measurable lesion per response evaluation criteria in solid tumors (RECIST) 1.1

9. While on study treatment and for 6 months after the last dose of study treatment, apatient must:

10. Not breast feed or be pregnant.

11. Not donate gametes (ie, eggs or sperm) or freeze for future use for the purposeof assisted reproduction.

12. Wear an external condom when engaging in any activity that allows for passageof ejaculate to another person.

13. If of childbearing potential i. Have a negative highly sensitive (eg, beta-human chorionic gonadotropin [β-hCG])pregnancy test at screening and within 72 hours before the first dose of studytreatment, and agree to further pregnancy tests, ii. Practice at least 1 highlyeffective method of contraception; if oral contraceptives are used, a barrier methodof contraception must also be used. e. If a patient's partner is of childbearing potential, the participant must use acondom and partner of the participant must also be practicing a highly effectivemethod of contraception. A vasectomized patient must still use a condom, but thepartner is not required to use contraception.

14. Resolution of prior-therapy-related AEs (including immune-related AEs but excludingalopecia) to ≤ Grade 1 per CTCAE v 5.0, and no treatment for these AEs for at least 2 weeks prior to the time of enrollment. Alopecia, sensory neuropathy Grade ≤ 2, orother Grade ≤ 2 AEs not constituting a safety risk based on investigator's judgmentare acceptable.

15. Adequate organ function as indicated by laboratory values.

16. Submit tissue and blood specimens.

17. Cohort 1:

18. All patients should submit tumor tissue/block collected from fresh biopsy orhave available archival formalin-fixed, paraffin-embedded tumor tissuespecimen. The archival tissue must be:

• collected after progression from most recent prior systemic anti-cancertreatment, OR
• If an archival tissue collected after progression to the most recentsystemic anti-cancer treatment is not available, tissue samples fromprevious lines of treatment are acceptable.For fresh biopsied sample, core needle biopsy is permitted. Samples fromfine-needle aspiration (FNA) is not acceptable unless the result of MET exon 14skipping from local testing is available.

2. All patients must submit blood samples.

3. Cohort 2:

4. All patients should submit either fresh or archival tumor slides/blockcollected after progression from 1st line 3rd generation EGFR TKI. The archivaltissue can be permitted ONLY IF it is collected after progression from 1st line 3rd generation EGFR TKI.

5. All patients should submit blood samples. 11. Able and willing to comply withthe protocol and the restrictions and assessments therein.

Exclusion Criteria:

1. Previous severe hypersensitivity reaction to any component of study drug(s).

2. Prior therapy a. Previous treatment with c-MET inhibitors or hepatocyte growth factor (HGF)-targeting therapy. b. For Cohort 2, prior chemotherapy for advanced, recurrent, or metastatic setting.

3. Genetic analysis results:

4. Cohort 1: Existing genetic data from the patient's tumor tissue showing knownmolecular alterations which would make them eligible for targeted therapies (e.g., EGFR mutations, ALK rearrangements, KRAS mutation, ROS1 translocation,BRAF mutation, RET alteration, and NTRK fusion, etc.).

5. Cohort 2: Patients with known molecular alterations that can't benefit fromstudy medication (e.g., EGFR mutation known to be associated with theresistance to 3rd generation EGFR TKIs, such as C797X or insertion 20, ALKrearrangements, KRAS mutation, ROS1 translocation, BRAF mutation, RETalteration, and NTRK fusion, etc.).

6. Chronic inflammatory liver condition. History or clinical evidence of anysignificant liver or biliary pathology including cirrhosis, infectious disease,inflammatory conditions, steatosis, or cholangitis (including ascending cholangitis,primary sclerosing cholangitis, obstruction, perforation, fistula of biliary tract,spasm of sphincter of Oddi, biliary cyst or biliary atresia).

7. Past medical history of Interstitial Lung Disease (ILD)/pneumonitis, drug-induced orradiation ILD/pneumonitis that required steroid treatment or other immunesuppressive agents, or evidence of current symptomatic interstitial lung disease orunexplained pulmonary symptoms indicative of ILD such dyspnea, cough, or fever.

8. Impairment of Gastrointestinal (GI) function or GI disease that may significantlyalter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea,uncontrolled vomiting, uncontrolled diarrhea, or malabsorption syndrome)

9. Prior organ or stem cell transplant.

10. Known active infection with human immunodeficiency virus (HIV), human T-cellleukemia virus, type (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV),unless the patients fall into below categories (patients fall into one of the a, b,c category are eligible to participate)

11. HIV ✓ CD4+ cells ≥ 350 cells/µL ✓ No history of AIDS ✓ No history of opportunistic infection in the past 12 months

12. HCV ✓ Undetectable viral load (Participants positive for hepatitis C antibody areeligible only if polymerase chain reaction is negative for hepatitis C RNA)

13. HBV ✓ Concurrent HBV treatment and undetectable viral load (Participants with apast or resolved hepatitis B infection defined as the presence of hepatitis Bcore antibody [anti-HBc] and absence of hepatitis B surface antigen areeligible)

14. Symptomatic ascites or pleural effusion, unless clinically stable for at least twoweeks following treatment for these conditions (including therapeutic thoraco- orparacentesis).

15. Known active central nervous system (CNS) primary tumor or metastases and/orcarcinomatous meningitis. Patients with previously treated brain metastases mayparticipate provided they are clinically stable for at least 4 weeks prior to firstdose of study medication(s), have no evidence of new or enlarging brain metastasesand are off steroids for at least 15 days prior to first dose of studymedication(s).

16. Presence or history of a malignant disease other than disease to be treated incurrent protocol that has been diagnosed and/or required therapy within the past 3years. Exceptions to this exclusion include the following: completely resected basalcell and squamous cell skin cancers, indolent malignancies that currently do notrequire treatment, and completely resected carcinoma in situ of any type.

17. Active infection requiring therapy. However, subject with minor infections requiringoral antibiotics, (e.g., urinary tract infection, Upper respiratory tract infection,etc.) could be eligible based on investigator's judgement.

18. Use of systemic corticosteroids > 10 mg/day prednisone or equivalent within 30 daysor other immunosuppressive drugs within 30 days prior to first drug administration.

19. Patients receiving treatment with medications that meet one of the followingcriteria and that cannot be discontinued specified period prior to the start oftreatment with study drug and for the duration of the study. For Vabametkib (Wash-out: 1 week)

• Strong and moderate inhibitors/inducers of P-glycoprotein

• Strong and moderate inhibitors/inducers of CYP3A4

• Proton pump inhibitors (PPI)

• Potassium-competitive acid blockers For Lazertinib

• Strong and moderate CYP3A4 inducers

• Medications possibly prolong QT interval or induce Torsades de Pointes

15. Has received or will receive a live vaccine within 30 days prior to the firstadministration of study medication. Seasonal flu vaccine that does not contain livevaccine are permitted.

16. Received an investigational product (except for EGFR TKI in Cohort 2) or treatedwith an investigational device within 30 days prior to first study drugadministration.

17. Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents ortyrosine kinase inhibitors (except for EGFR TKI in Cohort 2) within 2 weeks (4 weeksin case of thoracic radiotherapy to lung fields) or 5 half-lives (whichever islonger) of the start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study treatment; nitrosoureas, antibody-drug conjugates, orradioactive isotopes within 6 weeks of the start of study treatment; 7-day washoutis permitted for palliative radiation (i.e. limited field, ≤ 14-day course ofradiotherapy) to non-CNS lesions.

18. History or clinical evidence of any surgical or medical condition which theinvestigator judges as likely to interfere with the results of the study or pose anadditional risk in participating e.g., rapidly progressive or uncontrolled diseaseinvolving a major organ system-vascular, ophthalmologic, cardiac (clinicallyimportant abnormalities in rhythm, conduction or morphology of resting ECG,uncontrolled hypertension, uncontrolled symptomatic heart failure), pulmonary,gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal,endocrine, autoimmune or an immunodeficiency, or clinically significant activepsychiatric or abuse disorders.

19. Is a regular user (including "recreational use") of any illicit drugs or had arecent history (within the last year) of substance abuse (including alcohol).

20. Patients with a corrected QT interval (using Fridericia's correction formula) (QTcF)of > 470 msec.

21. Any factors that increase the risk of QTc prolongation or risk of arrhythmic eventssuch as, hypokalemia, congenital long QT syndrome, family history of long QTsyndrome, or unexplained sudden death under 40 years of age in first degreerelatives or any concomitant medications known to prolong QT interval or induceTorsades de Pointes.

22. Congestive heart failure (CHF), defined as New York Heart Association (NYHA) classIII-IV or hospitalization for CHF (any NYHA class), within 6 months ofrandomization.

23. An active or past medical history of pericarditis, pericardial effusion that isclinically unstable, or myocarditis. Pericardial effusion considered due to thedisease under study is permitted if clinically stable at Screening.

24. (for Cohort 2) Baseline LVEF either <50% or below the lower limit of normal (LLN)per institutional guidelines, as assessed by screening echocardiogram or MUGA scan.

25. (for Cohort 2) Patients who have been receiving medications with potential for QTinterval prolongation will be eligible only when the wash out period was finished.